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NCT Number: NCT07340632

B4P Trial - BLOOM43 for Preconditioning

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. This study aims to understand a participant's experience of the device, including its usability and acceptability.

Participants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).

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Key information

Conditions

Skin Necrosis Breast Reconstruction Breast Surgery Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All females over the age of 18 years (no maximum age limit)
  • Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and/or implant)

Exclusion criteria

  • Delayed (two-stage) breast reconstruction patients
  • Patients undergoing simple mastectomy or wide local excision of a breast tumour
  • Inflammatory breast cancer patients
  • Patients with ulcerated breast tumours
  • Patents with T4 breast cancer
  • Presence of open breast skin wounds, or infected or inflamed breast skin
  • Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

Treatment and study plan

BLOOM43

Device

BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.

Primary outcomes

  1. Safety of the device

    Time frame: 90 days

    Monitoring AEs, ARs, SAEs, SARs, UARs and USARs

  2. Participant experience

    Time frame: 30 days

    Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.

Secondary outcomes

  1. Mastectomy skin flap necrosis

    Time frame: 90 days

    Proportion of participants experiencing mastectomy skin flap necrosis and the rates of hospital re-admission and surgical re-intervention due to this

  2. Compliance

    Time frame: 1 day

    Proportion of participants who are compliant with the preconditioning protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Hadyn Kankam

CONTACT

[email protected]

Saahil Mehta

CONTACT

[email protected]

447711183551

Sponsors and collaborators

Lead sponsor

Plexaa Ltd

Industry

Collaborators

  • Portsmouth Hospitals NHS Trust
  • Royal Marsden NHS Foundation Trust

Registry information

Official study title

BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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